Delhi High Court refuses to restrain Natco from manufacturing spinal muscular atrophy drug

The Delhi High Court on Thursday upheld a single-judge's order refusing to restrain Hyderabad-based Natco Pharma from producing a drug used in the treatment of Spinal Muscular Atrophy (SMA) [F Hoffman- LA Roche Vs Natco Pharma].

A Division Bench of Justices C Hari Shankar and Ajay Digpaul dismissed Swiss drugmaker Roche’s appeal and agreed with the single-judge that Natco had raised a credible challenge to the validity of Roche’s patent for 'Risdiplam', the Active Pharmaceutical Ingredient in its commercial product "EVRYSDI®".

The Court also emphasised that appellate courts should not lightly interfere with discretionary orders refusing interim injunctions.

SMA is a debilitating neuromuscular disorder caused by mutations in the SMN1 gene, leading to progressive muscle weakness and, in severe cases, difficulty in breathing and swallowing.

Roche, claiming that Risdiplam was a novel chemical entity distinct from its earlier genus patent, had approached the Court after discovering that Natco had listed the drug among “APIs under development” and filed a 2022 patent application for an “Improved Process for the Preparation of Risdiplam.”

Roche sought to restrain Natco from manufacturing or selling the drug in India until expiry of its patent rights.

In March 2025, Justice Mini Pushkarna refused to grant Roche interim relief.

The single-judge held that Natco had raised a credible validity challenge, particularly in light of Roche’s own statements in foreign patent proceedings and Patent Term Extension applications, which suggested that Risdiplam was traceable to the earlier genus patent.

The Court also had heard patients with SMA, who highlighted that Roche’s pricing put the drug out of reach for most families.

"The approved drug, i.e., Risdiplam, which is marketed under the name Evrysdi, is not available at reasonably affordable prices in India. Thus, if a party is able to manufacture the drug and make it available at an affordable price, in such a case, the public interest would have to outweigh the need for grant of injunction," Justice Pushkarna said in the order passed on March 24.

Roche’s drug currently costs about ₹6.2 lakh per bottle, with annual treatment running from ₹70 lakh to over ₹1.4 crore depending on dosage and patient weight. Natco, by contrast, has publicly announced it will price its version at an MRP of ₹15,900 per bottle, bringing annual treatment down to an estimated ₹30–50 lakh.

Intervenors Purva Mittal and Seba PA, both SMA patients, had told the single-judge that Roche’s Patient Assistance Programme reached only a limited number of patients, leaving most without treatment. They argued that permitting generic supply was in the larger public interest.

Roche was represented by Senior Advocate Sandeep Sethi with advocates Pravin Anand, Archana Shanker, Shrawan Chopra, Prachi Agarwal, Devinder Rawat, Elisha Sinha, Achyut Tewari, Krisha Baweja, Aayush Maheshwari and Sumer Seth from Anand & Anand.

Natco was represented by Senior Advocate J Sai Deepak and advocates Afzal B Khan, Samik Mukherjee, Amrita Majumdar, Dominic Alvares, Avinash Kr Sharma and Sharad Besoya from S Majumdar & Co.